(TAMPA, FLORIDA, USA, 1 November 2012) – ISPE, a leading authority on
publishing best practices documents for the pharmaceutical industry, announced today that it has issued updated
guidance for GxP compliant laboratory computerized systems. The guidance has been revised to conform with
GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments. These
revisions support ISPE’s overall mission to help the industry focus attention on patient safety, product
quality and data integrity.

“As the industry continues to focus on solutions to quality issues, the industry’s reliance on laboratory
computer systems becomes more widespread, and automated laboratory testing and data management operations
continue to increase in sophistication and complexity,” said Christopher White a member of the team creating
this Guide. “At the same time, laboratory personnel typically lack expertise in implementing laboratory
systems. This Guide helps them understand the process so they can be effective in this area.”

The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory
Computerized Systems (Second Edition) contains steps that scientists, suppliers and others involved in
managing laboratory computerized system acquisition, implementation, and operations can use to verify
laboratory computerized systems are fit for their intended use. The Guide provides a practical, risk-based
approach, thus eliminating trial and error. Following the principles outlined in the Guide, companies can
save time and money, improve communication with external parties and achieve higher quality, better
performing systems.

About ISPEISPE, the International Society for Pharmaceutical Engineering, is the world’s largest
not-for-profit association serving its Members through leading scientific, technical and regulatory
advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions
in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical
delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide
headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.